Medical device with orientable tip for robotically directed laser cutting and biomaterial application

ABSTRACT

A medical device used in a medical robotic system has a conduit and an orientable tip. An optical fiber coupled to a laser source and/or a catheter coupled to one or more biomaterial sources extends through the conduit and tip so that the tip of the medical device may be robotically directed towards a target tissue for laser and/or biomaterial application as part of a medical procedure performed at a surgical site within a patient. A protective sheath covers the fiber as it extends through the conduit and tip. A first coupler adjustably secures at least the sheath to the medical device and a second coupler adjustably secures the fiber to at least the sheath. A similar dual coupler mechanism may be used to secure the sheathed catheter to the medical device.

FIELD OF THE INVENTION

The present invention generally relates to medical devices used inmedical robotic systems and in particular, to a medical device with anorientable tip for robotically directed laser cutting and biomaterialapplication during a medical procedure performed by a surgeon using amedical robotic system.

BACKGROUND OF THE INVENTION

Medical robotic systems such as those used in performing minimallyinvasive surgical procedures offer many benefits over traditional opensurgery techniques, including less pain, shorter hospital stays, quickerreturn to normal activities, minimal scarring, reduced recovery time,and less injury to tissue. Consequently, demand for such medical roboticsystems is strong and growing.

One example of such a medical robotic system is the da Vinci® SurgicalSystem from Intuitive Surgical, Inc., of Sunnyvale, Calif., which is aminimally invasive robotic surgical system. The da Vinci® SurgicalSystem has a number of robotic arms that move attached medical devices,such as an image capturing device and Intuitive Surgical's proprietaryEndoWrist® articulating surgical instruments, in response to movement ofinput devices by a surgeon viewing images captured by the imagecapturing device of a surgical site. Each of the medical devices isinserted through its own minimally invasive incision into the patientand positioned to perform a medical procedure at the surgical site. Theincisions are placed about the patient's body so that the surgicalinstruments may be used to cooperatively perform the medical procedureand the image capturing device may view it without their robotic armscolliding during the procedure.

In another example of a medical robotic system, a roboticallymanipulated endoluminal device may be employed that enters the patientthrough a single minimally invasive incision or through a body orifice,such as the mouth, rectum, vagina, or urethra, to reach a surgical ordiagnostic site within a patient by passing, at least partially alongwith way, through a natural body lumen. The endoluminal device in thiscase may integrate surgical instruments and an image capturing deviceinto one unit.

One application for such an endoluminal device is Natural-OrificeTransluminal Endosurgery (“NOTES”), which may involve, for example,passing flexible instruments through one of the body's orifices andentering the abdomen from the inside of the patient, rather than througha minimally invasive incision from the outside. For example, in“transgastric” surgery, instruments are passed through the mouth andinto the stomach. A hole is then cut in the stomach wall to perform amedical procedure within the abdominal cavity. Once the procedure iscompleted, the instruments are withdrawn along with any tissue removedduring the procedure, and the entry hole is stitched back up. Becausethe stomach wall has very few pain receptors, NOTES may be less painfulthan even minimally invasive surgery. Also, since it uses a natural bodyorifice instead of incisions to enter the body, it may result in reducedneeds for general anesthetics and faster recovery times.

Medical robotic systems such as these generally require surgicalinstruments that are capable of cutting, grasping, and suturing tissueto perform medical procedures. However, in endoluminal devices whichinclude integrated surgical instruments and an image capturing device,it may be difficult to ensure that the surgical instruments implementedtherein can always generate sufficient cutting force or adequatedexterity to accomplish their intended tasks. Further, due to the natureof such robotically controlled instruments, their manipulation may bedifficult to master for users of the medical robotic systems.

OBJECTS AND SUMMARY OF THE INVENTION

Accordingly, one object of one or more aspects of the present inventionis a medical device to be used in a medical robotic system that is easyfor an operator to use for performing a medical procedure at a surgicalsite within a patient.

Another object of one or more aspects of the present invention is amedical device to be used in a medical robotic system that does notrequire the need to generate large forces at its tip to perform itsintended task at a surgical site within a patient.

Still another object of one or more aspects of the present invention isa medical device to be used in a medical robotic system that does notinterfere with a camera's view while being used during the performanceof a medical procedure at a surgical site within a patient.

Yet another object of one or more aspects of the present invention is amedical device to be used in a medical robotic system that may beaccurately and reliably used during the performance of a medicalprocedure at a surgical site within a patient.

These and additional objects are accomplished by the various aspects ofthe present invention, wherein briefly stated, one aspect is a medicalrobotic system comprising: an input device; a manipulator; a medicaldevice coupled to the manipulator, the medical device having a conduitand an orientable tip, the orientable tip having a proximal end coupledto a distal end of the conduit; a catheter extending through the conduitand to a distal end of the orientable tip; a biomaterial source coupledto a proximal end of the catheter; and a processor configured to commandthe manipulator to manipulate the orientable tip so as to point a distalend of the catheter according to operator manipulation of the inputdevice.

Another aspect is a method for configuring a medical device forperforming a medical procedure using a medical robotic system,comprising: inserting a catheter through a conduit of the medical deviceso as to extend to a distal end of an orientable tip of the medicaldevice; coupling a biomaterial source to a proximal end of the catheter;and coupling the medical device to the medical robotic system so that aposition and orientation of a distal end of the catheter is controllableby controlling a position and orientation of the orientable tip throughoperator manipulation of an input device.

Another aspect is a medical device couplable to a medical roboticsystem, comprising: a conduit; a hollow tip; a wrist mechanism couplingthe hollow tip to the conduit so that respective passages in the conduitand the hollow tip are aligned; and an interface coupled to the wristmechanism and adapted to couple to the medical robotic system so thatthe medical robotic system controls movement of the wrist mechanismaccording to operator manipulation of an input device of the medicalrobotic system.

Still another aspect is a method for using method for using a medicaldevice in a medical robotic system, comprising: robotically manipulatinga tip of the medical device so as to point towards a target tissue whileactivating a laser beam through an optical fiber extending through themedical device to a distal end of the tip so as to selectively sever aportion of the target tissue; and robotically manipulating the tip ofthe medical device so as to point towards the target tissue whileselectively applying first and second biomaterials through separatelumens of a catheter extending through the medical device to the distalend of the tip so as to selectively apply a mixture of the first andsecond biomaterials to a non-severed portion of the target tissue.

Additional objects, features and advantages of the various aspects ofthe present invention will become apparent from the followingdescription of its preferred embodiment, which description should betaken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a top view of an operating room employing a medicalrobotic system utilizing aspects of the present invention.

FIG. 2 illustrates a top view of a medical device utilizing aspects ofthe present invention.

FIG. 3 illustrates a side view of a simple two-jointed tip of a medicaldevice utilizing aspects of the present invention.

FIG. 4 illustrates a side view of a multi-jointed tip of a medicaldevice utilizing aspects of the present invention.

FIG. 5 illustrates a side view of a conduit of a medical deviceutilizing aspects of the present invention.

FIG. 6 illustrates a cross-sectional view of a single-passage conduit ofa medical device utilizing aspects of the present invention.

FIG. 7 illustrates a cross-sectional view of a dual-passage conduit of amedical device utilizing aspects of the present invention.

FIG. 8 illustrates a top view of a prior art biomaterial applicatorincluded in a medical device utilizing aspects of the present invention.

FIG. 9 illustrates a cross-sectional view of a dual-lumen catheter of aprior art biomaterial applicator included in a medical device utilizingaspects of the present invention.

FIG. 10 illustrates a simplified top view of a robotic arm with attachedbiomaterial applicator medical device utilizing aspects of the presentinvention.

FIG. 11 illustrates a simplified top view of a robotic arm with attachedand remotely actuatable biomaterial applicator medical device utilizingaspects of the present invention.

FIG. 12 illustrates a simplified top view of a robotic arm with attachedlaser cutting medical device utilizing aspects of the present invention.

FIG. 13 illustrates a simplified top view of a robotic arm with attachedlaser cutting and remotely actuatable biomaterial applicator medicaldevice utilizing aspects of the present invention.

FIG. 14 illustrates a block diagram of medical robotic system includinga laser cutting and remotely actuatable biomaterial applicator medicaldevice utilizing aspects of the present invention.

FIG. 15 illustrates a flow diagram of a method for performing lasercutting and biomaterial application on target tissue, utilizing aspectsof the present invention.

FIG. 16 illustrates a simplified top view of a medical device with dualcouplers for coupling a sheathed optical fiber to the medical device,utilizing aspects of the present invention.

FIG. 17 illustrates a cross-sectional view of a conduit of a medicaldevice, utilizing aspects of the present invention, with a sheathedoptical fiber extending through a passage of the conduit.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 1 illustrates, as an example, a top view of an operating roomemploying a medical robotic system. The medical robotic system in thiscase is a minimally invasive robotic surgical system 100 including aConsole C utilized by a Surgeon S while performing a medical procedure,such as a diagnostic or surgical procedure, with assistance from one ormore Assistants A, on a Patient P who is lying down on an Operatingtable O.

The Console includes a monitor 104 for displaying a three-dimensional(“3-D”) image of a surgical site to the Surgeon, a processor 102, amicrophone 103, a foot pedal 105, and left and right manipulatable inputdevices 108, 109. The input devices 108, 109 may include any one or moreof a variety of control devices such as joysticks, gloves, trigger-guns,hand-operated controllers, or the like. The processor 102 may be adedicated computer integrated into the Console or positioned next ornear to it, or it may be broken up into a number of processing orcontroller components that are distributed in a distributed processingfashion throughout the System 100.

The Console is usually located in the same room as the Patient so thatthe Surgeon may directly monitor the procedure, is physically availableif necessary, and is able to speak to the Assistant(s) directly ratherthan over the telephone or other communication medium. However, it willbe understood that the Surgeon can also be located in a different room,a completely different building, or other remote location from thePatient allowing for remote medical procedures.

The Surgeon performs the medical procedure by manipulating the inputdevices 108, 109 so that the processor 102 causes associated ones of therobotic arms 121, 122, 123, 124 to move their respective removablycoupled medical devices 138, 139, 140, 200 while the Surgeon views thesurgical site on the Console monitor 104 as it is captured by an imagecapturing device 140. For example, robotic arms 121, 122 and theirrespective medical devices 138, 139, which are surgical instruments, maybe associated at one time during the medical procedure with the inputdevices 108, 109 so that the surgical instruments 138, 139 may berobotically moved by the Surgeon manipulating the input devices 108,109. At another time during the medical procedure, robotic arm 123 andits medical device 140, which is a stereoscopic endoscope, may beassociated with one of the input devices 108, 109 so that the endoscope140 can be properly positioned to view the medical procedure by theSurgeon manipulating its associated input device. At still another timeduring the medical procedure, robotic arm 124 and its medical device200, which provides laser cutting and/or biomaterial applicationcapability, may be associated with one of the input devices 108, 109 sothat the medical device 200 may be robotically moved by the Surgeonmanipulating its associated input device.

Each of the medical devices 138, 139, 140, 200, is conventionallyinserted through a tool guide (not shown) into the Patient so as toextend down to the surgical site through a corresponding minimallyinvasive incision such as Incision 161. The number of medical devicesused at one time and consequently, the number of robotic arms being usedin the system 100 will generally depend on the medical procedure beingperformed and the space constraints within the operating room, amongother factors. If it is necessary to change a medical device being usedduring a procedure, the Assistant may remove the medical device nolonger being used from its robotic arm, and replace it with anothermedical device 131 from a Tray T in the operating room.

Each of the robotic arms 121, 122, 123, 124 includes a slave manipulatorand setup arms. The slave manipulators are robotically moved using motorcontrolled joints (also referred to herein as “active joints”) in orderto manipulate and/or move their respectively held medical devices. Thesetup arms may be manually manipulated by releasing normally brakedjoints (also referred to herein as “setup joints”) to horizontally andvertically position the robotic arms 121, 122, 123, 124 so that theirrespective medical devices may be inserted into their respective toolguides. The robotic arms 121, 122, 123, 124 are attached to apatient-side cart 120 having wheels for easily moving it from onelocation to another.

The input devices 108, 109 are provided with at least the same degreesof freedom as their associated medical devices to provide the Surgeonwith telepresence, or the perception that the input devices 108, 109 areintegral with their associated medical devices so that the Surgeon has astrong sense of directly controlling the medical devices. Accordingly,position, force, and tactile feedback sensors are preferably employed onthe medical devices to transmit position, force, and tactile sensationsfrom the medical devices back to the Surgeon's hands as he/she operatesthe input devices 108, 109. Tactile feedback is especially useful whenthe medical devices being controlled are the surgical instruments 138,139.

Preferably, the monitor 104 is positioned near the Surgeon's hands sothat it will display a projected image that is oriented so that theSurgeon feels that he or she is actually looking directly down onto theoperating site. Accordingly, images of the surgical instruments 138, 139appear to be located substantially where the Surgeon's hands are locatedwhen they are associated with the input devices 108, 109. In addition,the real-time image is projected into a perspective image such that theSurgeon can manipulate the end effectors of the surgical instruments138, 139 through their associated input devices 108, 109 as if viewingthe workspace in substantially true presence. By true presence, it ismeant that the presentation of an image is a true perspective imagesimulating the viewpoint of an operator that is physically manipulatingthe surgical instruments 138, 139. Thus, the processor 102 transformsthe coordinates of the surgical instruments 138, 139 to a perceivedposition so that the perspective image is the image that one would seeif the endoscope 140 was located directly behind the surgicalinstruments 138, 139.

The processor 102 performs various functions in the system 100 includingthe performance of certain methods described herein. One importantfunction that it performs is to translate and transfer the mechanicalmotion of input devices 108, 109 to the slave manipulators of associatedrobotic arms through control signals over bus 110 so that the Surgeoncan effectively manipulate their respective medical devices.

Although described as a processor, it is to be appreciated that theprocessor 102 may be implemented in practice by any combination ofhardware, software and firmware. Also, its functions as described hereinmay be performed by one unit, or divided up among different components,each of which may be implemented in turn by any combination of hardware,software and firmware.

For additional details on the construction and operation of a medicalrobotic system such as described herein, see, e.g., commonly owned U.S.Pat. No. 6,493,608 “Aspects of a Control System of a Minimally InvasiveSurgical Apparatus,” and commonly owned U.S. Pat. No. 6,671,581 “CameraReferenced Control in a Minimally Invasive Surgical Apparatus,” whichare incorporated herein by reference.

FIG. 2 illustrates, as an example, one embodiment of the medical device200 which provides optical laser and/or biomaterial applicationcapability. The laser may be used for many purposes such as cutting,coagulation, ablation, illumination, and other known medical uses forlasers. Laser cutting provides a number of advantages over conventionalcutting tools such as scissors and scalpels attached as end effectors tomedical devices, such as the surgical instruments 138, 139. First ofall, it may be difficult to generate sufficient cutting or shearingforces for such scissors and scalpel tools in a minimally invasiverobotic surgical system (or endoluminal device), and laser cuttingeliminates the need for the generation of such forces. Secondly, it maybe difficult for the Surgeon to learn to use such scissors and scalpeltools in an endoluminal robot since the Surgeon must manipulate themfrom a flexible robotic platform and therefore, generally may have to doso with reduced degrees of freedom and sensory control. In contrast,learning to simply direct a tip of a medical device with laser cuttingcapability is presumably easier to learn and more accurate for cutting.

The capability to easily and accurately apply biomaterials (such asthose having hemostatic, adhesive, or adhesion barrier characteristics)to targeted tissue is also useful during or after the performance of amedical procedure on a patient using a minimally invasive roboticsurgical system (or endoluminal device). The capability to applybiomaterials having adhesive characteristics is particularly useful asan alternative to suturing.

For example, BioGlue® Surgical Adhesive (“BioGlue”), a surgical adhesiveproduct of CryoLife, Inc. of Kennesaw, Ga., is delivered as a two partliquid (49% concentrated bovine serum albumin and 10% glutaraldehyde)that rapidly polymerizes after mixing to form an impermeable seal ontissue. BioGlue is characterized by a quick bonding time independent ofthe body's clotting mechanisms. Upon mixing, the two componentscross-link to each other and to cell surface proteins and extracellularmatrix proteins at the repair site of application. It begins to bondwithin 20 to 30 seconds of mixing and reaches its maximal bondingcapability in two minutes, creating a flexible mechanical seal.

Another biomaterial mixture having hemostatic and/or adhesive qualitiesis fibrin, which is applied as a two-component mixture in which asolution of concentrated fibrinogen and factor XIII are combined with asolution of thrombin and calcium in order to form a coagulum, simulatingthe final stage of the clotting cascade. Once mixed, a fibrin clot formsin a few seconds, or somewhat slower if a more dilute form of thrombinis used. In some preparations, or in selected indications, anantifrinolytic agent (aprotinin) is included to prevent lysis of theclot.

The medical device 200 comprises a conduit 201 having one or morepassages through which an optical fiber and/or a multi-lumen catheterfor applying biomaterials may be removably inserted, an interface 202for interfacing with the robotic arm 124 to which the medical device 200is mechanically and electrically coupled, a mechanical coupler 203 forholding the inserted optical fiber and/or multi-lumen catheter, and anorientable tip 204 which is mechanically coupled to the interface 202 sothat it may be robotically controlled to bend in different directions inresponse to operator manipulation of an associated one of the inputdevices 108, 109. Proximal end(s) 212 of the inserted optical fiberand/or multi-lumen catheter extend out of the interface 202 at one endof the medical device 200, and distal end(s) 211 of the inserted opticalfiber and/or multi-lumen catheter extend to an open end of theorientable tip 204 at the other end of the medical device 200.

FIG. 3 illustrates, as an example, a simple two joint orientable tip204′ that is controllably orientable in pitch and roll angulardirections about a longitudinal axis of the conduit 201. A first section301 couples to a distal end of the conduit 201 so that it rotates whenthe conduit 201 is rotated by its robotic arm 124 to provide acontrollable 360 degree roll angular movement. Section 321 iscontrollably pivotable about joint 322 by at least ±45 degrees andlikewise, section 311 is controllably pivotable about joint 312 by atleast ±45 degrees. As a result, the distal end of the tip 204 isorientable by approximately ±90 degrees or more about the joint 312 inthe pitch angular direction relative to the longitudinal axis of theconduit 201. Thus, the orientable tip 204′ comprises three sections 301,311, 321 which operate as a “wrist” mechanism that allows controlledpointing of the tip 204′ within a cone-like area having a vertex at thepivot joint 312 and a central axis along the longitudinal axis 501 ofthe conduit 201.

When the orientable tip 204′ is coupled to the conduit 201, definedpassages 305, 315, 325 within the sections 301, 311, 321 of the tip 204′align with corresponding passages 221 of the conduit 201 so that anoptical fiber and/or multi-lumen catheter extending through the passages221 of the conduit 201 may pass through the passages 305, 315, 325 ofthe orientable tip 204′ to a distal end 330 of the tip 204′.

FIG. 4 illustrates, as a more sophisticated example, a four jointorientable tip 204 that is controllably orientable in pitch, roll andyaw angular directions relative to the longitudinal axis of the conduit201. In this example, four sections are shown, each comprising a pair ofdisk segments pivotably coupled together by an intervening strut. Thefirst and fourth sections provide controllable yaw angular movement, andthe second and third sections provide controllable pitch angularmovement. The tip 204 is coupled to a distal end of the conduit 201 sothat it rotates when the conduit 201 is rotated by its robotic arm 124to provide controllable 360 degree roll angular movement.

The second section includes disk segments 403, 404 and dual pivots 413,414, which provide at least ±45 degrees controllable pitch angularmovement about one or the other of the pivots 413, 414. Similarly, thethird section includes disk segments 404, 405 and dual pivots 415, 416which provide at least ±45 degrees controllable pitch angular movementabout one or the other of the pivots 415, 416. As a result, the distalend of the tip 204 is controllably orientable by at least ±90 degreesabout one or the other of the pivots 413, 414 in the pitch angulardirection relative to the longitudinal axis of the conduit 201.

The first and fourth sections are 90 degrees offset (i.e., rotatedapproximately 90 degrees in the roll direction relative to thelongitudinal axis of the conduit 201) from the first and fourthsections. The first section includes disk segments 401, 402 and dualpivots 411, 412 (not seen because of their 90 degree offset from dualpivots 413, 414) which provide at least ±45 degrees controllable yawangular movement about one or the other of the pivots 411, 412.Similarly, the fourth section includes disk segments 407, 408 and dualpivots 417, 418 (not seen because of their 90 degree offset from dualpivots 415, 416) which provide at least ±45 degrees controllable yawangular movement about one or the other of the pivots 417, 418. As aresult, the distal end of the tip 204 is controllably orientable by atleast ±90 degrees about one or the other of the pivots 411, 412 in theyaw angular direction relative to the longitudinal axis of the conduit201.

Cables 421, 422 extend from a conventional motor driven pulleyarrangement (not shown) in the interface 202 to the disk segment 404 sothat by pulling one or the other of the cables 421, 422, the disksegment 404 may be pivoted about the pivots 413, 414 in one direction orthe other. Similarly, other cable pairs (not shown) extend from otherconventional motor driven pulley arrangements (not shown) in theinterface 202 to their respective disk segments so that by pulling oneor the other of the cables in the pair, the disk segment may be pivotedabout its pivot joint in one direction or the other.

As in the tip 204′ described in reference to FIG. 3 above, passages (notshown) are defined within the sections of the tip 204 so as to alignwith corresponding passages 221 of the conduit 201 so that an opticalfiber and/or multi-lumen catheter extending through the passages 221 ofthe conduit 201 may pass through the section passages to a distal end430 of the orientable tip 204.

The dual pivots of each section of the tip 204 are coupled through thesection's strut so that “cable balancing” is achieved wherein the cablelength paid out on one side is equal to the cable length pulled on theother side of the disk segment. For additional details on such “cablebalancing” and the construction and operation of the wrist mechanism ofthe orientable tip 204, as well as the construction and operation ofother wrist mechanisms that may be alternatively used in the tip 204,see commonly owned U.S. Pat. No. 6,817,974, “Surgical Tool havingPositively Positionable Tendon-Actuated Multi-Disk Wrist Joint,” whichis incorporated herein by reference.

FIGS. 5˜7 illustrate examples of one or more passages 221 extendingthrough and along the length of the conduit 201. In the case where onlyone passage 221 is provided, the passage 221 may be centered in theconduit so that its central axis aligns with the central axis 501 of theconduit 201 (as shown in partial side view of the conduit 201 in FIG. 5and cross-sectional view of the conduit 201 in FIG. 6). In this case, anoptical fiber and multi-lumen catheter may take turns being inserted inthe single passage 221 so that each only resides in the passage 221 whenit is needed and is removed when not needed.

On the other hand, in the case where two passages 221 are provided, thepassages 221 may be vertically centered and horizontally side-by-side sothat their central axes are parallel with the central axis 501 of theconduit 201 (as shown in partial side view of the conduit 201 in FIG. 5and cross-sectional view of the conduit 201 in FIG. 7). In this case,both passages 221 may be used at the same time with the optical fiber inone and the multi-lumen catheter in the other. Other shapes, sizes,numbers and geometrical arrangements of passages 221 may also beimplemented in the medical device 200, and are fully contemplated asbeing within the full scope of the present invention.

FIG. 8 illustrates, as an example, a top view of a biomaterialapplicator 800 which includes a multi-lumen catheter 805 and a syringeassembly 810, and FIG. 9 illustrates, as an example, a cross-sectionalview of the multi-lumen catheter 805. A biomaterial applicator such asdescribed in reference to FIGS. 8˜9 is commercially available fromMicromedics, Inc. of St. Paul, Minn.

The syringe assembly 810 includes a first syringe 820 which may befilled with a first biomaterial 821 and a second syringe 830 which maybe filled with a second biomaterial 831. A V-shaped neck 811 couples thefirst and second syringes 820, 830 respectively to the first and secondlumens 801, 802 of the catheter 805. A connecting structure 812 couplestogether first and second plungers 822, 832 of the first and secondsyringes 820, 830 so that when the connecting structure 812 is movedtowards the catheter 805, the first and second plungers 822, 832 moveaccordingly to force the first and second biomaterials 821, 831 throughthe first and second lumens 801, 802 of the catheter 805. The first andsecond biomaterials 821, 831 forced out of the distal end of thecatheter 805 then form a mixture upon their exits of the first andsecond lumens 801, 802 of the catheter 805, such as in the case ofBioGlue® or fibrin.

FIG. 10 illustrates, as an example, a simplified view of the robotic arm124 with the biomaterial applicator 800 inserted into the medical device200 by passing the catheter 805 of the biomaterial applicator 800through the interface 202 and conduit 201 of the medical device 200until a distal end of the catheter 805 exits a distal end of theorientable tip 204 of the medical device 200, and securing thebiomaterial applicator 800 in that position by using the coupler 203.After using the biomaterial applicator 800, it may be removed from themedical device 200 by releasing the coupler 203, and extracting thecatheter 805 from the conduit 201 and interface 202 of the medicaldevice 200. The biomaterial applicator 800 may then be cleaned andreused at a later time, or it may be disposed of. Thus, the biomaterialapplicator 800 is a removably disposable component of the medical device200.

FIG. 11 illustrates, as an example, a simplified view of the robotic arm124 with the biomaterial applicator 800 inserted into the medical device200, as described in reference to FIG. 10, with an actuator 1110 coupledto the connecting structure 812 of the biomaterial applicator 800 so asto be capable of moving the plungers 822, 832 to expel the first andsecond biomaterials 821, 831 out of the first and second lumens 801, 802of the catheter 805 of the biomaterial applicator 800 when commanded todo so by, for example, the Surgeon depressing a designated button on oneof the input devices 108, 109 associated at the time with the medicaldevice 200. Note that if such an actuator is not provided, as in thecase with the configuration shown in FIG. 10, the connecting structure812 of the biomaterial applicator 800 may still be manually actuated byan Assistant, who is positioned near the robotic arm 124, at the requestof the Surgeon communicating with the Assistant either directly if theis within hearing distance, or from a distance using the microphone 103and a speaker (not shown) located within the Assistant's hearingdistance.

FIG. 12 illustrates, as an example, a simplified view of the robotic arm124 with an optical fiber 1300 inserted into the medical device 200 bypassing the optical fiber 1300 through the interface 202 and conduit 201of the medical device 200 until a distal end of the optical fiber 1300exits a distal end of the orientable tip 204 of the medical device 200,and securing the optical fiber 1300 in that position by using thecoupler 203. The optical fiber 1300 is connected to a laser source 1310so that a laser beam may be directed out of the distal end of theoptical fiber 1300 upon activation of the laser source 1310 by, forexample, the Surgeon depressing a designated button on one of the inputdevices 108, 109 associated at the time with the medical device 200.After using the optical fiber 1300, it may be removed from the medicaldevice 200 by releasing the coupler 203, and extracting the opticalfiber 1300 from the conduit 201 and interface 202 of the medical device200.

FIG. 13 illustrates, as an example, a simplified view of the robotic arm124 with both the optical fiber 1300 and the biomaterial applicator 800inserted into the medical device 200. In this case, the conduit 201 ofthe medical device 200 has first and second passages 221, for example,such as shown in FIG. 7, with the optical fiber 1300 extending throughthe first passage and the catheter 805 of the biomaterial applicator 800extending through the second passage. Separate couplers 222, 223 areprovided to respectively secure the catheter 805 and the optical fiber1300 once they have been properly inserted as described in reference toFIGS. 10 and 12. Extraction of the optical fiber 1300 and catheter 805may also be performed as described in reference to FIGS. 10 and 12 afterreleasing their respective couplers 222, 223.

FIG. 14 illustrates, as an example, a block diagram of the medicalrobotic system 100, which is adapted with a laser cutting (and otherpurposes) and remotely actuatable biomaterial applicator medical device200 such as shown and described in reference to FIG. 13. The inputdevice 108 may be selectively associated with the robotic arm 124holding the medical device 200 or the robotic arm 121 holding thesurgical instrument 138. The Surgeon may select which robotic arm is tobe associated with which input device by using a pointing device (notshown) and a Graphical User Interface (“GUI”) associated with themonitor 104. Alternatively, the Surgeon may perform such selection byspeaking commands into the microphone 103 that are recognized by voicerecognition software being executed by the processor 102. In eithercase, the processor 102 performs the association by transmitting commandinformation from the input device to the associated robotic arm and itsattached medical device.

When the Surgeon moves the input device 108, the movement is detected byjoint encoders 1401 in the input device 108. The joint encoders 1401provide the movement information to the processor 102, which convertsthe information into commands transmitted over the bus 110 to move themedical device 200 and/or its tip 204 accordingly. For example, movementof the medical device 200 may be effected by commanding the robotic arm124 to move the medical device 200 as desired, and movement of theorientable tip 204 of the medical device 200 may be effected bycommanding motor driven pulley arrangements in the interface 202 of themedical device 200 to be actuated as described in reference to FIGS. 3and 4.

After the Surgeon has positioned the medical device 200 at a properdistance from a target tissue and directed its tip 204 so as to pointtowards the target tissue by moving the input device 108, the Surgeonmay then perform either laser or biomaterial application on the targettissue. For example, if laser cutting is to be performed on the targettissue, then the Surgeon may activate a laser switch 1403 (such as athumb depressible button on the input device 108, a foot switch on thefoot pedal 105, or a voice command spoken into the microphone 103 thatis recognized by voice recognition software implemented in the processor102) that causes the laser source 1310 to be turned on, while moving theinput device 108 with his or her hand so as to cause the tip 204 of themedical device 200, and consequently, a laser beam emanating from theoptical fiber 1300 coupled to the laser source 1310, to be directed tothe area of the target tissue to be cut.

On the other hand, if biomaterial application is to be performed on thetarget tissue, then the Surgeon may activate an actuator switch 1402(such as a thumb depressible button on the input device 108, a footswitch on the foot pedal 105, or a voice command spoken into themicrophone 103 that is recognized by voice recognition softwareimplemented in the processor 102) that causes the syringe actuator 1110to force biomaterials concurrently out of the first and second syringes820, 830 so as to form a biomaterial mixture as they are expelled out ofthe first and second lumens 801, 802 of the catheter 805, while movingthe input device 108 with his or her hand so as to cause the tip 204 ofthe medical device 200, and consequently, the biomaterial mixture beingemitted from the catheter 805, to be directed to the area of the targettissue upon which the biomaterial mixture is to be applied.

FIG. 15 illustrates, as an example, a flow diagram of a method utilizingthe processor 102 for performing laser cutting and biomaterialapplication on target tissue. In 1501, a position (and/or movement) ofthe input device 108 is detected by the processor 102 (e.g., frominformation provided by the joint encoders 1401 in the input device108). In 1502, a determination is made whether the input device 108 ispresently associated with the robotic arm 121 (to which the surgicalinstrument 138 is coupled) or the robotic arm 124 (to which the medicaldevice 200 is coupled). If the input device 108 is presently associatedwith the robotic arm 121, then in 1503, the processor 102 causes therobotic arm 121 and/or an end effector of its coupled surgicalinstrument 138 to be moved accordingly. On the other hand, if the inputdevice 108 is associated with the robotic arm 124, then in 1504, theprocessor 102 causes the robotic arm 124 and/or the tip 204 of itscoupled medical device 200 to be moved accordingly. Note that if theinput device 108 is not a shared input device (e.g., it is configured tobe fixedly associated with the robotic arm 124 of the medical device200), then 1502 and 1503 are unnecessary, and the method proceedsdirectly from 1501 to 1504.

After or concurrently with the movement commanded in 1504, adetermination is made in 1505 whether the laser switch 1403 is activated(e.g., whether a thumb depressible button on the input device 108 isbeing depressed at the time). If the determination in 1505 is YES, thenin 1506, the laser source 1310 is turned ON, and the method loops backto 1501 to detect and process a subsequent position (and/or movement) ofthe input device 108. On the other hand, if the determination in 1505 isNO, then the method proceeds to 1507.

In 1507, a determination is made whether the actuator switch 1402 isactivated (e.g., whether another thumb depressible button on the inputdevice 108 is being depressed at the time). If the determination in 1507is YES, then in 1508, the syringe actuator 1110 is actuated, and themethod loops back to 1501 to detect and process a subsequent position(and/or movement) of the input device 108. On the other hand, if thedetermination in 1507 is NO, then the method loops back to 1501 withoutactuating the syringe actuator 1110.

Note that although the description above in reference to FIG. 15indicates that the method determines whether the laser switch 1403 isactivated before determining whether the actuator switch 1402 isactivated, it is to be appreciated that the order of such determinationsmay be reversed or the determinations may be made concurrently. Further,if an optical fiber has not been inserted in the medical device 200,then the determination made in 1505 may be skipped altogether.Similarly, if a catheter of a biomaterial applicator has not beeninserted in the medical device 200, then the determination made in 1507may be skipped altogether.

Also, although the use of laser and actuator switches 1403, 1402included in the input device 108 are described herein for activatinglaser cutting and biomaterial application, it is to be appreciated thatother activation techniques may be used, such as, for example, voiceactivation using the microphone 103 and conventional voice recognitionsoftware executed by the processor 102. In the case of voice activation,when the voice recognition software recognizes the Surgeon's voicecommand to activate laser cutting, it may set a laser flag stored in thememory of the processor 102, so that in 1505, the processor 102 wouldcheck the status of the laser flag instead of whether the laser switchdescribed therein has been switched on. Similarly, when the voicerecognition software recognizes the Surgeon's voice command to activatebiomaterial application, it may set an actuator flag stored in thememory of the processor 102, so that in 1507, the processor 102 wouldcheck the status of the actuator flag instead of whether the actuatorswitch described therein has been switched on.

A laser and biomaterial applying medical device employing aspects of thepresent invention as described herein is useful in a number ofapplications. For example, in “transgastric” surgery where anendoluminal device may be passed through the mouth and into the stomachof the Patient, the Surgeon may use the laser cutting capability to cuta hole in the stomach wall so that the endoluminal device may enter theabdominal cavity and perform a medical procedure therein. Once themedical procedure is completed, the endoluminal device may be withdrawnfrom the abdominal cavity and the Surgeon may then use the biomaterialapplicator capability to seal the hole previously cut in the stomachwall. Other applications involving cutting or severing diseased tissuefor removal from adjoining tissue and adhering the non-severed adjoiningtissue back together (such as in a coronary artery bypass procedure) mayalso be performed using the medical device 200 in conjunction withsurgical instruments having grasping end effectors (or a flexibleendoluminal device incorporating aspects of the present invention asdescribed herein in reference to the medical device 200).

Although a single coupler 203 is shown in FIG. 12 for coupling theoptical fiber 1300 to the interface 202 of the medical device 200, adual coupler scheme, such as shown in FIG. 16, may better secure theoptical fiber 1300 when placed within a protective sheath 1600 passingthrough the shaft 201 of the medical device 200 during its use in amedical procedure. A similar dual coupler scheme may also be used forattaching the biomaterial applicator 800 to the medical device 200 whenits catheter 805 is sheathed.

Referring to FIG. 16, the sheath 1600 is a long flexible tube that isinserted into a proximal end of the interface 202 and passed through theinterface 202 and the shaft 201 until a distal end of the sheath 1600exits the tip 204 of the medical instrument 200. The optical fiber 1300is then inserted through the protective sheath 1600 until it also exitsand extends out of the tip 204 by a workable amount designated as thedistance “X”. FIG. 17 illustrates a cross-sectional view cut along line“C” of the shaft 201 with the protective sheath 1600 and optical fiber1300 inserted therein.

During a medical procedure, it is important to maintain the distance “X”that the optical fiber 1300 extends out of the tip 204 of the medicaldevice 200 in order to ensure even lasing operation. Therefore, theoptical fiber 1300 and its protective sheath 1600 should be secured insome fashion to the medical device 200 so as to prevent such movement ofthe optical fiber 1300. To this end, dual couplers 1610, 1620 areemployed.

Each of the couplers 1610, 1620 is constructed so that it may securelyhold a cable or other structure passing through its central bore. As anexample, the couplers 1610, 1620 may be Tuohy-Borat fittings. The firstcoupler 1610 attaches to the interface 202 so that after passing thesheathed optical fiber 1300 through it, the coupler 1610 may be turnedso as to compress an O-ring 1611 within it around the sheath 1600 andoptical fiber 1300 to secure them in place. The sheath 1600 in this caseis also compressible to an extent so that when the O-ring 1611compresses it, it is forced against the optical fiber 1300 passingthrough it so as to hold the optical fiber 1300 in place.

However, because the O-ring 1611 is not being compressed directlyagainst the optical fiber 1300, the optical fiber 1300 may slip in thesheath 1600 and disadvantageously move during the medical procedure. Forthis reason, a second coupler 1620 may be employed that is attached to aproximal end of the sheath 1600 so that after passing the optical fiber1300 through it, the coupler 1620 may be turned so as to compress anO-ring 1621 within it around the optical fiber 1300 to secure theoptical fiber 1300 in place.

The first coupler 1610 is attached to the interface 202, for example, bya luer-lock fitting (not shown), which is a tapered twist-lockconnection. The coupler 1610 is thus free to slide along the sheath 1600until secured to the sheathed fiber 1300 as described above. This allowsthe sheath 1600 to be positioned accurately in relation to the medicaldevice 200 and facilitates different length medical devices and medicaldevice tips. The second coupler 1620 is attached to the proximal end ofthe sheath 1600, for example, by a similar tapered, twist-lockconnection. Alternatively, other well known attaching means may be used.

Although the various aspects of the present invention have beendescribed with respect to one or more preferred embodiments, it will beunderstood that the invention is entitled to full protection within thefull scope of the appended claims.

I claim:
 1. A medical system comprising: an input device; a manipulator;a medical device coupled to the manipulator, the medical device having aconduit and an orientable tip, the orientable tip having a proximal endpivotally coupled to a distal end of the conduit; a catheter extendingthrough the conduit and to a distal end of the orientable tip, whereinthe catheter has first and second lumens; a first biomaterial fluidsource coupled to a proximal end of the first lumen of the catheter forproviding a first biomaterial fluid through the first lumen; a secondbiomaterial source coupled to a proximal end of the second lumen of thecatheter for providing a second biomaterial fluid through the secondlumen; and a processor programmed to command the manipulator tomanipulate the orientable tip so as to point a distal end of thecatheter according to operator manipulation of the input device andprogrammed to cause the first and second biomaterial fluids to flowthrough and exit out of a distal end of the catheter in response to anapplication command.
 2. The medical system according to claim 1, furthercomprising: an actuator coupled to the first and second biomaterialfluid sources; wherein the processor is further configured to commandthe actuator to feed first and second biomaterial fluids from the firstand second biomaterial fluid sources through the first and second lumensso as to be mixed when exiting at the distal end of the catheter inresponse to the application command.
 3. The medical system according toclaim 2, wherein the mixture of the first and second biomaterial fluidshas hemostatic characteristics.
 4. The medical system according to claim2, wherein the mixture of the first and second biomaterial fluids hasadhesive characteristics.
 5. The medical system according to claim 2,wherein the mixture of the first and second biomaterial fluids hasadhesion barrier characteristics.
 6. The medical system according toclaim 2, wherein the application command is generated by operation of afirst switch mechanism included in the input device.
 7. The medicalsystem according to claim 2, further comprising: a second input device;wherein the application command is generated by operation of a firstswitch mechanism included in the second input device.
 8. The medicalsystem according to claim 2, further comprising: a voice recognitionsystem; wherein the application command is generated by the voicerecognition system in response to a first operator voice command.
 9. Themedical system according to claim 1, further comprising: an opticalfiber extending through the conduit to the distal end of the orientabletip; and a laser source coupled to a proximal end of the optical fiber.10. The medical system according to claim 9, wherein the processor isfurther configured to cause the laser source to lase through the opticalfiber in response to a lase command.
 11. The medical system according toclaim 10, wherein the lase command is generated by operation of a secondswitch mechanism included in the input device.
 12. The medical systemaccording to claim 10, further comprising: a second input device;wherein the lase command is generated by operation of a second switchmechanism included in the second input device.
 13. The medical systemaccording to claim 10, further comprising: a voice recognition system;wherein the lase command is generated by the voice recognition system inresponse to a second operator voice command.
 14. A method forconfiguring a medical device for performing a medical procedure using amedical system, comprising: inserting a catheter through a conduit ofthe medical device so as to extend to a distal end of an orientable tipof the medical device, wherein the orientable tip is pivotally coupledto the conduit; coupling a first biomaterial fluid source to a proximalend of a first lumen of the catheter so as to be capable of providing afirst biomaterial fluid through the first lumen; coupling a secondbiomaterial fluid source to a proximal end of a second lumen of thecatheter so as to be capable of providing a second biomaterial fluidthrough the second lumen; coupling the medical device to the medicalrobotic system so that a position and orientation of a distal end of thecatheter is controllable by controlling a position and orientation ofthe orientable tip through operator manipulation of an input device; andcoupling an actuator to the first and second biomaterial sources so thatthe first and second biomaterial fluids flow through and are mixed afterexiting a distal end of the catheter in response to an applicationcommand.
 15. The method according to claim 14, further comprising:inserting an optical fiber through the conduit of the medical device soas to extend to the distal end of the orientable tip of the medicaldevice; and coupling a laser source to a proximal end of the opticalfiber.